Acute Coronary Syndrome Study

• Principal Investigator

  Samin K. Sharma

• Compensation

  N

• URL

  http://www.clinicaltrial.gov

• Inclusion

  1. The people has been hospitalized for heart attack (Unstable Angina with or without ST segment elevation myocardial infarction. 2. The people are able to initiate study drug: a) Within 7 days of the index event, and b) Within 48 +/- 12 hours after discontinuation of acute medical treatment for the index event (ie, other anticoagulants, fibrinolytic therapy, or glycoprotein IIb/IIIa antagonists), and c) Within 48 +/- 12 hours after completion of PCI (if performed). 3. The people has at least 1 of the following additional ischemic risk factors: a) Age =65 years. b) Previous heart attack c) The person goes to hospital due to heart attack d) Presence of multi-vessel coronary disease e) History of symptomatic congestive heart failure f) History of stroke or transient ischemic attack more than 12 months prior enrollment. g) Presence of peripheral arterial obstructive disease. h) Diabetes mellitus requiring medical therapy to maintain glycemic control. i) Current smoker (smokes a tobacco product at least 3 times daily). 4. The people or the legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures. 5. A female person of childbearing potential who is sexually active must agree to use adequate contraception from Screening until 30 days after receiving the last dose of study drug. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as at least 2 years since last regular menses).

• Exclusion

  1. The person is <30 or >80 years of age. 2. The person has low body weight (<50 kg). 3. The person has severe hypertension (systolic blood pressure =180 mm Hg or diastolic blood pressure =110 mm Hg). 4. The person has a known bleeding/clotting disorder 5. The person has a history of bleeding in the brain or inside the eyes 6. The person has a history of gastrointestinal bleeding or ulcers (gastric or duodenal within 12 months prior to enrollment 7. The person has a history of ischemic stroke or transient ischemic attack within 12 months prior to enrollment 8. The person has had major surgery, including coronary artery bypass graft (CABG), within 3 months prior to enrollment 9. The person has a history of cancer. 10. The person has kidney disease 11. The person has anemia or low platelet count (less than100,000UL) 12. The person has active liver disease (including hepatitis C), or jaundice that has not resolved prior to enrollment 13. The person has a history of illicit drug use or excessive alcohol intake within 2 years prior to enrollment 14. If a female person is pregnant or lactating. 15. The person has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow up the subject 16. The person has received TAK-442 in a previous clinical study or as a therapeutic agent. 17. The person has a history of hypersensitivity or allergies to other factor 10a inhibitors. 18. The person has received any investigational compound within 30 days prior to screening or is currently participating in another investigational study. 19. The person is a study site employee or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study. 20. The person is unable to provide informed consent or is unwilling or unable to understand or comply with the protocol or scheduled appointments. 21. Persons have undergone non-major laparoscopic surgery or non-major minimally invasive surgery within 2 weeks prior to re-randomization.

• Sponsoring Organization

  Mount Sinai Medical Center

• Department Name

  MSSM Cardiovascular Institute

• Contact Information

  Kameswari Vallabhajosyula [Coordinator]
  N/A
  kameswari.vallabhajosyula@msnyuhealth.org
  
  212-241-5696 45696

• GCO Number

  09-0246

• IRB Start/End Date

  June 26, 2009 to March 23, 2010